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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

31.07.2026 19:58

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NOVEOS X

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600138
Basic UDI-DI: 695441761106R72T
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

MQ-8000

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600077
Basic UDI-DI: 69544176150180YJ
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

MQ-6000

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600060
Basic UDI-DI: 69544176120160XB
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

MQ-2000PT

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600053
Basic UDI-DI: 695441760901PT5X
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

MQ-3000

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600022
Basic UDI-DI: 6954417609073023
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

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Immunodiagnostic Products Signal Reagent

500mL

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005692
Basic UDI-DI: 69543760F0003164
Reference: 69543760F0003164
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:27

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Sample Diluent 5

30mL

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005265
Basic UDI-DI: 69543760F000386J
Reference: 69543760F000386J
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:27

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Sample Diluent 4

30mL

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substances

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005258
Basic UDI-DI: 69543760F000376G
Reference: 69543760F000376G
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent 3

30mL

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect marking

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005241
Basic UDI-DI: 69543760F000366E
Reference: 69543760F000366E
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:27

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Sample Diluent 2

30mL

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect marking

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005234
Basic UDI-DI: 69543760F000356C
Reference: 69543760F000356C
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent 1

30mL

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesMicrobial substances

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005227
Basic UDI-DI: 69543760F000346A
Reference: 69543760F000346A
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

Concentrated Wash Solution

2.5L

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005210
Basic UDI-DI: 69543760F0003368
Reference: 69543760F0003368
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

10L

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005203
Basic UDI-DI: 69543760F0003266
Reference: 69543760F0003266
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

CI 1200 Automated Chemiluminescence Immunoassay Analyzer

CI 1200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005180
Basic UDI-DI: 69543760Y00001DJ
Reference: 69543760Y00001DJ
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

CI 2000S Automated Chemiluminescence Immunoassay Analyzer

CI 2000S

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005173
Basic UDI-DI: 69543760Y00002DL
Reference: 69543760Y00001DJ
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic Chemiluminescence analyzer

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825645
Basic UDI-DI: 69528048CLI1000XN4
Reference: CLI1000X
EMDN: W0201010280
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Immersion Oil

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Baso Diagnostics Inc. Zhuhai
Manufacturer SRN: CN-MF-000050424
UDI-DI: 06952383305460
Basic UDI-DI: 695238330005GK
Reference: 1000ml
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062778066
Basic UDI-DI: 69520627J012L3
Reference: SL030101NST-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CE14-COVAg-6.6 · Rev. A/4
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062774020
Basic UDI-DI: 69520627J034LD
Reference: CFRA1ST-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CE80-CFRA-6-6 · Rev. A7
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA)

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712367
Basic UDI-DI: 69520627J161LM
Reference: CFRAH1NST-1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-CFRAH-6.6 · Rev. A1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details